Third Molar SurgeryNCT07243210
Effect of Irrigation Solution Temperature on Clinical Outcomes and Salivary CRP After Impacted Mandibular Third Molar Surgery
A study testing Cold Saline Irrigation in people with Third Molar Surgery and Postoperative Complications, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Surgical extraction of impacted mandibular third molars often requires bone removal using rotary instruments, in which friction between the bur and bone generates heat. Excessive temperature rise may lead to local bone necrosis, delayed healing, and increased postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Third Molar Surgery, Postoperative Complications, C-REACTIVE PROTEIN
- What is being tested?
- Cold Saline Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients with an ASA physical status classification of I or II.
- Patients with bilaterally impacted mandibular third molars of comparable difficulty, with an angulation difference between the two teeth not exceeding 15 degrees, confirmed by clinical and panoramic radiographic examination.
- Patients who have provided written informed consent after being fully informed about the study purpose and procedures.
Who cannot join
- Patients presenting with systemic or local acute inflammation or infection at the surgical site.
- Patients with systemic diseases contraindicating surgical tooth extraction.
- Patients with a history of corticosteroid or anti-inflammatory drug use within 3 weeks prior to participation.
- Patients with clinical or radiographic signs suggestive of tumors (benign or malignant) associated with or adjacent to the impacted mandibular third molar.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Effect of Irrigation Solution Temperature on Clinical Outcomes and Salivary CRP After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial
Surgical extraction of impacted mandibular third molars often requires bone removal using rotary instruments, in which friction between the bur and bone generates heat. Excessive temperature rise may lead to local bone necrosis, delayed healing, and increased postoperative complications. Continuous irrigation with saline solution is routinely performed to reduce heat generation, and cold saline irrigation (0-4℃) has been shown to provide better thermal control than room-temperature saline.
This study aims to evaluate the effect of cold saline irrigation compared with room-temperature saline irrigation on postoperative outcomes following impacted mandibular third molar surgery. The assessed parameters include pain, swelling, trismus, and salivary C-reactive protein (CRP) levels as a biomarker of inflammation. Salivary CRP serves as a minimally invasive marker that reflects the systemic inflammatory response after surgery.
Read more
This randomized controlled trial will be conducted at the University of Medicine and Pharmacy at Ho Chi Minh City. Eligible patients with bilateral impacted mandibular third molars will be enrolled. Each patient will undergo extraction of one tooth with cold saline irrigation (0-4℃) and the contralateral tooth with room-temperature saline irrigation. Postoperative outcomes will include pain intensity (VAS) on days 1, 2, and 7; facial swelling on days 1, 2, and 7; trismus on days 1, 2, and 7; and salivary CRP levels at baseline and postoperative day 2.
The findings are expected to clarify the role of irrigation solution temperature in both subjective clinical outcomes and objective inflammatory markers, thereby providing evidence to optimize clinical protocols and reduce postoperative morbidity in third molar surgery.
- Being tested
- Cold Saline Irrigation, Room-Temperature Saline Irrigation (Control)
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Saline IrrigationProcedure or surgery
During surgical extraction of impacted mandibular third molars, bone removal and irrigation will be performed using sterile saline cooled to 0-4°C to minimize heat generation
Room-Temperature Saline Irrigation (Control)Procedure or surgery
During surgical extraction of impacted mandibular third molars, bone removal and irrigation will be performed using sterile saline at room temperature (approximately 25°C). This procedure serves as the control to compare the effects of irrigation temperature on postoperative outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Cold Saline Irrigation | Experimental | Not described Receives: Procedure: Cold Saline Irrigation |
| Room-Temperature Saline Irrigation | Active comparator | Not described Receives: Procedure: Room-Temperature Saline Irrigation (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Facial Swelling
Facial swelling will be assessed by measuring three linear distances between standard facial landmarks: (1) tragus to pogonion, (2) gonion to lateral canthus, and (3) gonion to commissure.
Postoperative swelling is measured as the change in facial dimension at each time point compared with the baseline measurement.
Measured: Baseline (preoperative) and postoperative days 1, 2, and 7
Postoperative Pain
Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain.
Measured: Day 1, Day 2, and Day 7 after surgery
Trismus
Trismus will be evaluated by measuring the maximum interincisal distance (in millimeters) between the incisal edges of the upper and lower central incisors using a calibrated caliper.
The degree of trismus will be determined by the reduction in mouth opening compared with the baseline (preoperative) measurement.
Measured: Baseline (preoperative) and postoperative days 1, 2, and 7
Salivary C-Reactive Protein (sCRP) Levels
Salivary C-reactive protein (sCRP) levels will be quantified using the ELISA method following the manufacturer's protocol
Measured: Baseline and postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Sep 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Third Molar SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Huynh Thien An, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243210
- Sponsor's protocol ID
- Irrigation-CRP-2025
- Other IDs
- 269/2024/HĐ-ĐHYD
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen VK, Nguyen TN, Tran TLA, Lam CP, Le HTA. Clinical Outcomes and Salivary C-Reactive Protein Levels Following Mandibular Third Molar Surgery with Cold Saline Irrigation: A Randomized Split-Mouth Clinical Trial. Eur J Dent. 2026 Aug 14. doi: 10.1055/s-0046-1825975. Online ahead of print.
PubMed 42601037
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Irrigation Solution Temperature on Clinical Outcomes and Salivary CRP After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07243210
- Acronym / sponsor ID
- Irrigation-CRP-2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical extraction of impacted mandibular third molars often requires bone removal using rotary instruments, in which friction between the bur and bone generates heat. Excessive temperature rise may lead to local bone necrosis, delayed healing, and increased postoperative complications. Continuous irrigation with saline solution is routinely performed to reduce heat generation, and cold saline irrigation (0-4℃) has been shown to provide better thermal control than room-temperature saline.
This study aims to evaluate the effect of cold saline irrigation compared with room-temperature saline irrigation on postoperative outcomes following impacted mandibular third molar surgery. The assessed parameters include pain, swelling, trismus, and salivary C-reactive protein (CRP) levels as a biomarker of inflammation. Salivary CRP serves as a minimally invasive marker that reflects the systemic inflammatory response after surgery.
This randomized controlled trial will be conducted at the University of Medicine and Pharmacy at Ho Chi Minh City. Eligible patients with bilateral impacted mandibular third molars will be enrolled. Each patient will undergo extraction of one tooth with cold saline irrigation (0-4℃) and the contralateral tooth with room-temperature saline irrigation. Postoperative outcomes will include pain intensity (VAS) on days 1, 2, and 7; facial swelling on days 1, 2, and 7; trismus on days 1, 2, and 7; and salivary CRP levels at baseline and postoperative day 2.
The findings are expected to clarify the role of irrigation solution temperature in both subjective clinical outcomes and objective inflammatory markers, thereby providing evidence to optimize clinical protocols and reduce postoperative morbidity in third molar surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Saline Irrigation | Experimental | Procedure: Cold Saline Irrigation |
| Room-Temperature Saline Irrigation | Active comparator | Procedure: Room-Temperature Saline Irrigation (Control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy patients with an ASA physical status classification of I or II.
- Patients with bilaterally impacted mandibular third molars of comparable difficulty, with an angulation difference between the two teeth not exceeding 15 degrees, confirmed by clinical and panoramic radiographic examination.
- Patients who have provided written informed consent after being fully informed about the study purpose and procedures.
Key exclusion criteria (4 listed)
- Patients presenting with systemic or local acute inflammation or infection at the surgical site.
- Patients with systemic diseases contraindicating surgical tooth extraction.
- Patients with a history of corticosteroid or anti-inflammatory drug use within 3 weeks prior to participation.
- Patients with clinical or radiographic signs suggestive of tumors (benign or malignant) associated with or adjacent to the impacted mandibular third molar.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Saline IrrigationDuring surgical extraction of impacted mandibular third molars, bone removal and irrigation will be performed using sterile saline cooled to 0-4°C to minimize heat generation | Procedure or surgery | Cold Saline Irrigation |
| Room-Temperature Saline Irrigation (Control)During surgical extraction of impacted mandibular third molars, bone removal and irrigation will be performed using sterile saline at room temperature (approximately 25°C). This procedure serves as the control to compare the effects of irrigation temperature on postoperative outcomes. | Procedure or surgery | Room-Temperature Saline Irrigation |
Primary outcome
Postoperative Facial Swelling
Time frame: Baseline (preoperative) and postoperative days 1, 2, and 7
Facial swelling will be assessed by measuring three linear distances between standard facial landmarks: (1) tragus to pogonion, (2) gonion to lateral canthus, and (3) gonion to commissure. Postoperative swelling is measured as the change in facial dimension at each time point compared with the baseline measurement.
Postoperative Pain
Time frame: Day 1, Day 2, and Day 7 after surgery
Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain.
Trismus
Time frame: Baseline (preoperative) and postoperative days 1, 2, and 7
Trismus will be evaluated by measuring the maximum interincisal distance (in millimeters) between the incisal edges of the upper and lower central incisors using a calibrated caliper. The degree of trismus will be determined by the reduction in mouth opening compared with the baseline (preoperative) measurement.
Salivary C-Reactive Protein (sCRP) Levels
Time frame: Baseline and postoperative day 2
Salivary C-reactive protein (sCRP) levels will be quantified using the ELISA method following the manufacturer's protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Derived from this study: PubMed 42601037Nguyen VK, Nguyen TN, Tran TLA, Lam CP, Le HTA. Clinical Outcomes and Salivary C-Reactive Protein Levels Following Mandibular Third Molar Surgery with Cold Saline Irrigation: A Randomized Split-Mouth Clinical Trial. Eur J Dent. 2026 Aug 14. doi: 10.1055/s-0046-1825975. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Saline Irrigation in people with Third Molar Surgery and Postoperative Complications, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Facial Swelling (time frame: Baseline (preoperative) and postoperative days 1, 2, and 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07243210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.